IDM UID

22MFG4
VERSION CREATED ON / VERSION / STATUS

11 May 2018 / 5.1 / Approved

EXTERNAL REFERENCE / VERSION

MQP Procedure

ITER Procurement Quality Requirements

This document establishes the ITER Procurement Quality requirements to be implemented
regarding the procurement of items, services and IOproject activities.These requirements
apply to all activities performed for the IO by Domestic Agencies and outside organisations.

Approval Process
Name Action Affiliation
Author Jourdan T. 11 May 2018:signed IO/DG/QMD
Co-Authors
Reviewers Crowther D. IO/DG/RCO/FPD/PCD/EPS
Elbez-Uzan J. 29 May 2018:recommended IO/DG/RCO/SD/EPNS
Neagu S. 14 May 2018:reviewed IO/DG/QMD
Zhao Z. 28 May 2018:recommended IO/DG/QMD
Approver Tada E. 03 Jul 2018:approved IO/DG/RCO
Document Security: Internal Use
RO: Fabre Nadine
Read Access LG: Quality Control Group, AD: ITER, AD: External Collaborators, AD: IO_Director-General, AD: EMAB,
AD: OBS - Quality Management Division (QMD) - EXT, AD: OBS - Quality Management Division (QMD),
AD: Auditors, AD: ITER Management Assessor, project administrator, RO, LG: 5th working group, LG:
[CCS] ...

PDF generated on 03 Jul 2018

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 Change Log

ITER Procurement Quality Requirements (22MFG4)

Version Latest Status Issue Date Description of Change

v1.0 In Work 14 Dec 2005

v2.0 Signed 14 Dec 2005

v2.1 Signed 14 Jun 2007
v3.0 Signed 20 Nov 2007
v3.1 Approved 23 Nov 2007
v4.0 Approved 31 Mar 2009
v5.0 Approved 17 Mar 2015 Changes according to MQP doc Request - QX8F5H:
- Abstract changed
- Template changed for MQP Detailed Policy
- “should” changed to “shall” throughout the whole document
- General Revision incorporating the definition of a Critical Quality Activity
and definitions of approval, acceptance and for information.
- The requirements for PAs and Cash Procurements are now separated and
requirements for R & D activities clarified
v5.1 Approved 11 May 2018 As per MQP doc Request - WK7APM
Includes Module H needs

PDF generated on 03 Jul 2018

DISCLAIMER : UNCONTROLLED WHEN PRINTED – PLEASE CHECK THE STATUS OF THE DOCUMENT IN IDM
 Table of Contents

1 PURPOSE ............................................................................................................................2
2 SCOPE .................................................................................................................................2
3 DEFINITIONS AND ACRONYMS ..................................................................................2
4 REFERENCES....................................................................................................................2
5 ITER PROCUREMENT QUALITY CLAUSES .............................................................2
5.1 QUALITY MANAGEMENT SYSTEM ......................................................................................2
5.2 R&D ACTIVITIES ...............................................................................................................3
5.3 DESIGN ..............................................................................................................................3
5.4 QUALIFICATION OF SPECIAL PROCESSES ............................................................................3
5.5 MANUFACTURING, INSPECTION AND TESTING ...................................................................4
5.6 MEASURING AND TEST EQUIPMENT ...................................................................................4
5.7 HANDLING, STORAGE AND SHIPPING .................................................................................4
5.8 DEVIATIONS AND NON-CONFORMANCES ...........................................................................4
5.9 ACCEPTANCE AND DELIVERY ............................................................................................5
5.10 PERSONNEL TRAINING AND QUALIFICATION......................................................................5
5.11 ACCESS ..............................................................................................................................5
6 APPLICABLE ITER QUALITY DOCUMENTS ...........................................................5
7 SUMMARY OF QUALITY REQUIREMENTS ACTIONS ..........................................5

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1 Purpose
This document specifies IO Procurement Quality requirements to be implemented regarding the
procurement of items, services and IO project activities. These IO Procurement Quality
requirements are referred to in this document as IO Procurement Quality Clauses.

2 Scope
These requirements apply to all activities performed for the IO by Domestic Agencies and
outside organisations.
NOTE: Methods and solutions other than those set out in this document:
• may be acceptable provided they result in at least the same level of quality
• shall be subject to IO Quality Assurance Division written acceptance prior to
implementation.

3 Definitions and acronyms

IO ITER Organization sometimes referred to as ITER
Domestic Agency An organization set up under the ITER Framework Agreement to provide
goods or services to the ITER Organisation through Procurement
Arrangements (PA) and Task Agreements (TA)
Supplier Any entity that provides goods or services to the ITER Organisation
Subcontractor An entity that performs work for the Supplier
Performer An all-inclusive term used to cover Domestic Agencies, Suppliers and
Subcontractors
Contract An all-inclusive term used to cover Procurement Arrangements, Task
Agreements and Contracts placed directly by the IO
Critical Quality Any activity or operation that if not performed correctly may affect
Activity safety, functionality or reliability
Approval Formal agreement for the use or application of a product or document.
The approver takes responsibility for the use
Acceptance Acknowledgement that a product or document is in compliance with the
contractual requirements
For Information Documents sent for information require no further decision i.e. they
require neither acceptance nor approval
Equipment In this document Pressure Equipment and Nuclear pressure Equipment
are so called Equipment
Manufacturer Any natural or legal person who manufactures an equipment or has an
equipment designed or manufactured and markets under his name or
trademark
Pressure Vessels, piping, pressure accessories and safety accessories, including
Equipment / where applicable element permanently attached to pressure parts in the
Nuclear Pressure scope of PED or French ESPN Order
Equipment
PED Pressure Equipment Directive
ESPN Order French Regulation for Nuclear Pressure Equipment

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4 References
ITER Quality Assurance Program (QAP) (22K4QX)

5 ITER Procurement Quality Clauses

5.1 Quality Management System
The performers of IO project activities shall establish and implement a quality system
capable of ensuring that:
 contract requirements are met
 evidence of such compliance is maintained

The quality assurance system implemented by these various performers shall:

 be based on a recognized quality standard meeting the ITER Quality Assurance
Program requirements
 encompass all activities performed in connection with the IO project activities
 be described in a document to be accepted for use by the IO or DAs as
appropriate (see paragraph 7)

All performers shall establish a dedicated Quality Plan [1] for managing each IO project
activity and shall ensure that each supplier/subcontractor implements an effective
quality system. The performers shall undertake all necessary actions to establish and
maintain quality in locations within suppliers/subcontractor’s premises where IO related
work is conducted.

A Responsible Point of Contact shall be appointed to:

 coordinate the planning and performance of the work, including work assigned to
subcontractors
 keep time schedules and issue monthly progress reports
 verify that the quality systems are consistently followed during the performance
of the contract
 assess and oversee quality in subcontractors premises
 monitor the implementation of ITER Procurement Quality Requirements
 provide IO with periodic assessment of quality performance

5.2 R&D Activities

For R&D work, unless otherwise specified, only the DA (for Task Agreements) or Main
Supplier (for Direct Procurements) is required to submit a Quality Plan, however where R&D
prototypes are used to qualify manufacturing processes or produce equipment that may be used
in ITER, the full Procurement Quality Requirements will apply.
For R&D activities, where performers do not have an established quality system (typically
Institutions/Universities), they must provide a Quality Plan to IO detailing how the activities will
be managed and how the results will be validated.

5.3 Design
Where design is done by performers, acceptance of the final design must be given by IO prior to
commencement of manufacture unless otherwise agreed in the contract.
When IO acts as manufacturer of equipment final design including design done by performer
shall be approved by IO.

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The preparation, review, and approval of design documents for the assigned tasks shall be
accomplished through controlled procedures that establish the approval authorities and
responsibilities.

5.4 Qualification of Special Processes

Proposals for qualification of Special Processes such as welding, heat treatment, brazing etc.
must be submitted for IO review.
IO reserves the right to witness the qualification and testing of Special Processes.
Records of approval verifying process parameters, materials and test results must be reviewed
and accepted by IO prior to use in manufacturing.
When IO acts as manufacturer of equipment qualification of special processes shall be carried
out according to the requirements of “Implementation plan for design & manufacture of PE/NPE
in accordance with applicable regulation. (VE2DSP)”

5.5 Manufacturing, Inspection and Testing

Suppliers and Subcontractors shall not start work on any contract without a Quality
Plan in place that has been accepted by the IO (see paragraph 7). It is DA responsibility
to ensure this in the case of Procurement Arrangements.
Suppliers and Subcontractors shall not start manufacturing operations on any contract
without a Manufacturing and Inspection Plan (MIP) in place that has been accepted by
the IO (see paragraph 7). It is DA responsibility to ensure this in the case of
Procurement Arrangements.
Manufacture, inspection and testing shall be carried out:
 following pre-established lists of operations in accordance with the
‘Manufacturing and Inspection Plan’ document [2]
 using approved and up-to-date drawings, procedures, instructions, standards or
other documents directly accessible to those carrying out the work
Processes that cannot be adequately inspected after completion shall be performed
according to qualified procedures implemented by qualified personnel. Evidence of
qualification shall be available for IO review prior to use.
Inspection and testing status of items and services shall be readily identified.
Evidence of validation of computers and automated machining and inspection programs
and software shall be maintained.

5.6 Measuring and Test Equipment

Equipment used for process monitoring, data collection, inspections and tests shall be of
the proper range, type, accuracy and precision.
Calibration of measuring and test equipment used for process monitoring, data
collection, inspections and tests shall be maintained in accordance with:
 manufacturer's recommendations
 a calibration program based on a recognized standard
Calibration records shall be kept and current calibration status shall be readily
identified.

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 5.7 Handling, Storage and Shipping
Where specific handling, storage or shipping conditions are required, documented
procedures shall be submitted and accepted by the IO.
When IO acts as manufacturer of equipment handling, storage or shipping procedures
shall be approved by IO.

5.8 Deviations and Non-Conformances

Deviations and non-conformances shall be processed in accordance with the
‘Deviations and Non-Conformances’ document [3]:
 Technical changes that may be necessary or advisable in the course of a contract
must be agreed with IO prior to implementation. Records of this agreement must
be available at the performer’s premises.
 Conditions adverse to quality, which may occur during manufacture, inspection or
testing, must be reported to the IO, resolved and documented.

5.9 Acceptance and Delivery

Prior to acceptance, delivery or payment, a review of items and services status with respect to
contract requirements and regulatory requirements when applicable shall be made and
documented. This review will be done in accordance with the ‘Release Note’ document [4].

5.10 Personnel Training and Qualification

Personnel performing activities affecting quality shall have appropriate competence:
 to perform their assigned work
 to understand the quality consequences of their activities
Standard of Qualification of each item and service shall be in accordance with
specifications supplied by the IO.
When IO acts as manufacturer of equipment qualification of personnel shall be carried
out according to the requirements of “Implementation plan for design & manufacture of
PE/NPE in accordance with applicable regulation. (VE2DSP)”
Records of training, qualification and experience shall be available for IO review.

5.11 Access
Performers shall arrange for IO representatives to have access to the premises,
including those of suppliers/subcontractors, where work is performed for IO activities.
Mandatory and optional inspections shall be carried out in accordance with the
‘Manufacturing and Inspection Plan’. In addition, access must be available to IO
representatives throughout the manufacturing stage to perform unscheduled visits at any
location where ITER related work is being performed. This would normally be to verify
compliance with procedures and manufacturing requirements. Where DAs are involved,
these visits will be coordinated through the DA and justification will be given by IO on
a case by case basis.
Planned and documented audits will be performed by IO, and regulatory body
representatives in France, to verify compliance with the technical and quality
requirements of the contract. Auditors must have access to perform unscheduled visits

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to the performer’s facilities for the duration of the audit in order to pursue any audit
trails.
IO overseeing of the performance of the contract shall not relieve the performer of any
contractual obligations and responsibilities.

6 Applicable ITER Quality Documents

The requirements specified in the following ITER quality documents are an integral
part of the requirements of the present specification:
[1] Requirements for Producing a Quality Plan (22MFMW)
[2] Requirements for Producing a Manufacturing and Inspection Plan (22MDZD)
[3] Requirements for DA / Supplier / Subcontractors Deviations & Nonconformities (22F53X)
[4] Requirements for Producing a Contractors Release Note (22F52F)
For R&D activities or supply of services, Manufacturing and Inspection Plans and
Release Notes are not normally required.

7 Summary of Quality Requirements Actions

The following tables give an overview of the ITER quality requirements specified in the
applicable ITER Procurement Documents for Procurement Arrangements and for Direct
IO procurements.
Procurement Document Submittal Requirements
for Procurement Arrangements
Prior to contract implementation DA to submit a description of the successful
Tender’s Quality Assurance system for IO
information
Prior to contract implementation Obtain IO acceptance of DA and
Suppliers/Subcontractors dedicated Quality
Plans
Prior to start of manufacturing Obtain IO acceptance and mark-up of
Suppliers/Subcontractors Manufacturing and
Inspection Plan (MIP)
During manufacture  Update Quality Plans and MIPs as necessary
and seek IO re-acceptance
 Notify IO representatives of any pending
Inspection points as marked up on the MIP
 Complete the relevant entries in the MIP as
work progresses.
During contract implementation Issue Deviation Requests and Non-
Conformance Reports as necessary
Prior to delivery Complete the Release Note
Notes summarizing actions related to Procurement Arrangements
1. Each DA has a QA Program that is reviewed and approved for compliance with the IO
QA Program.
2. Each DA Tenderer shall supply the DA with a description of their Quality Assurance
System identifying compliance standards and accreditations and specifying the
elements they plan to use for the contract.

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3. After award of the contract, the DA shall send the above description from the
successful tenderer to the IO for information.
4. Quality Plans are produced by the DAs, Suppliers and Subcontractors (unless
otherwise agreed between the parties) describing how they will implement the ITER
Procurement Quality Requirements. DA approved Quality Plans are accepted by the
IO; approved Supplier Quality Plans are accepted by the DA and then accepted by IO;
approved Subcontractor Quality Plans are accepted by the Supplier, then accepted by
the DA, then sent to IO for acceptance.
5. Manufacturing and Inspection Plans (MIPs) are produced and approved by each Supplier
and Subcontractor, unless otherwise agreed between the parties. The DA marks up its
intended intervention points on the Supplier’s MIP, accepts the plan and sends it to IO
for acceptance and mark-up of any IO interventions. The Supplier marks up its intended
intervention points on the Subcontractor’s MIP, accepts the plan and sends it to the DA.
The DA marks up its intended intervention points on the Subcontractor’s MIP, accepts
the plan and sends it to IO for acceptance and mark-up of any IO interventions.

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 Procurement Document Submittal Requirements
for Direct IO procurement
Prior to Tender Potential Tenderers shall submit a description
(pre-qualification) of the Quality Assurance system for IO
acceptance
With Tender Reply Potential Suppliers shall submit to IO a
provisional Quality Plan for IO information
Prior to contract implementation Obtain IO acceptance of a Supplier dedicated
Quality Plan and IO acceptance of
Subcontractors dedicated Quality Plan
Prior to start of manufacturing Obtain IO acceptance and mark-up of Supplier
Manufacturing and Inspection Plan (MIP) and
IO acceptance / mark-up of Subcontractors
MIP
During manufacture  Update Quality Plans and MIPs as necessary
and seek IO re-acceptance
 Notify IO representatives of any pending
Inspection points as marked up on the MIP
 Complete the relevant entries in the MIP as
work progresses.
During contract implementation Issue Deviation Requests and Non-
Conformance Reports as necessary
Prior to delivery Complete the Release Note
Notes summarizing actions related to Direct IO procurement
1. Prior to the Tender, each potential Tenderer shall submit a description of the Quality
Assurance system for IO acceptance.
2. Each Tenderer shall supply to IO a provisional Quality Plan identifying how they intend
to implement the ITER Procurement Quality Requirements.
3. Quality Plans are produced by Suppliers and Subcontractors (unless otherwise agreed
between the parties) describing how they will implement the ITER Procurement Quality
Requirements. Supplier approved Quality Plans are accepted by the IO, Subcontractors
approved Quality Plans are accepted by the Supplier, then sent to IO for acceptance.
4. Manufacturing and Inspection Plans (MIPs) are produced and approved by each
Supplier and Subcontractor, unless otherwise agreed between the parties. The IO marks
up its intended intervention points on the Supplier’s MIP and accepts the plan. The
Supplier marks up its intended intervention points on the Subcontractor’s MIP, accepts
the plan and sends it to the IO. The IO marks up its intended intervention points on the
Subcontractor’s MIP and accepts the plan.

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